The effect of over-the-counter ranitidine 75 mg on night-time heartburn in patients with erosive oesophagitis on daily proton pump inhibitor maintenance therapy.

BACKGROUND

H2-receptor antagonists are widely used with proton pump inhibitors.

AIM: To determine if H2-receptor antagonists used in conjunction with proton pump inhibitors were effective for nocturnal heartburn in patients taking proton pump inhibitors.

METHODS

We evaluated 386 patients with erosive oesophagitis documented at endoscopy who were receiving single daily maintenance proton pump inhibitor therapy to determine if they had symptoms of nocturnal heartburn. Patients with two or more episodes of night-time a week were invited to participate in the study. Patients were randomly assigned to a single dose of an over-the-counter preparation of ranitidine 75 mg at bedtime or matching placebo for 14 days.

RESULTS

The prevalence of nocturnal symptoms was 10.6%. Mean symptom scores on the first day of the trial (baseline) were similar between the treatment group (1.1 +/- 0.9) and the placebo group (1.1 +/- 1.1). On day 3, symptom scores were significantly lower in the ranitidine group (0.71 +/- 0.69) compared with the control group (1.4 +/- 1.2; P = 0.045). On day 14, mean symptom scores were similar in the ranitidine group (0.82 +/- 0.95) and the control group (1 +/- 0.84).

CONCLUSIONS

Nocturnal heartburn is uncommon on proton pump inhibitor therapy; the addition of ranitidine at bedtime resulted in a decrease in symptom scores on day 3 but there were no differences on day 14.